Clinical trial · Interventional
The Effect of Cryocompression on Peripheral Neuropathy in Patients Receiving Chemotherapy for Gynecological Cancer
NCT07131618CI-TRIAL-00093910CryoPNnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study Design: This study is designed as a prospective, randomized controlled experimental study aiming to determine the effect of cryocompression therapy, applied during chemotherapy, on peripheral neuropathy symptoms in women with gynecologic cancers. Research Hypotheses: * H₀: Cryocompression therapy has no effect on peripheral neuropathy. * H₁: Cryocompression therapy has an effect on peripheral neuropathy. Study Population: The study population will consist of women over the age of 18 living in Mersin, Türkiye, who are diagnosed with gynecologic cancer and undergoing chemotherapy between August 10 and December 31, 2025.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecological Cancers | — | UNRESOLVED | — |
| Peripheral Neuropathy Due to Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cryocompression | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- intervention
- interventionNames
- Other: cryocompression
- type
- NO_INTERVENTION
- label
- control
Primary outcomes (1)
- measure
- Chemotherapy-Induced Peripheral Neuropathy Assessment Tool
- timeFrame
- One week after each chemotherapy cycle (6 weeks total).
- description
- Change in peripheral neuropathy severity measured by the Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) Scale range: 0 to 80 (higher scores indicate more severe neuropathy symptoms). Time Frame: One week after each weekly chemotherapy cycle, for six cycles (total 6 weeks). Description: Peripheral neuropathy severity will be assessed using the CIPNAT scale, which evaluates sensory, motor, and autonomic symptoms associated with chemotherapy-induced peripheral neuropathy. Scores from all six cycles will be summed for analysis.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Applying to Mersin University Hospital Oncology Outpatient Clinic * Willing to participate and providing signed informed consent * Able to read and write in Turkish * Accessible and able to communicate * Citizen of the Republic of Türkiye * Diagnosed with gynecologic cancer (ovarian, endometrial, or cervical) and aged ≥18 years * Receiving weekly carboplatin + paclitaxel chemotherapy protocol * No subjective peripheral neuropathy symptoms before starting chemotherapy * No history of peripheral neuropathy related to previous taxane/platinum-based chemotherapy protocols * No psychiatric disorders * No diseases that may cause peripheral neuropathy such as diabetes, rheumatoid arthritis, or fibromyalgia Exclusion Criteria: * Not applying to the specified outpatient clinic * No gynecologic cancer diagnosis or younger than 18 years old * Not providing informed consent * Not receiving weekly carboplatin + paclitaxel chemotherapy protocol * Presence of subjective peripheral neuropathy symptoms before starting chemotherapy * History of peripheral neuropathy related to previous taxane/platinum-based chemotherapy protocols * Presence of psychiatric disorders * Having diseases that may cause peripheral neuropathy such as diabetes, rheumatoid arthritis, or fibromyalgia
References
Publications (4)
- RESULTChitkumarn P, Rahong T, Achariyapota V. Efficacy of Siriraj, in-house-developed, frozen gloves for cold therapy reduction of chemotherapy-induced peripheral neuropathy in gynecological cancer patients: randomized controlled trial. Support Care Cancer. 2022 Jun;30(6):4835-4843. doi: 10.1007/s00520-022-06890-1. Epub 2022 Feb 11. PMID 35147758
- RESULTScotte F, Tourani JM, Banu E, Peyromaure M, Levy E, Marsan S, Magherini E, Fabre-Guillevin E, Andrieu JM, Oudard S. Multicenter study of a frozen glove to prevent docetaxel-induced onycholysis and cutaneous toxicity of the hand. J Clin Oncol. 2005 Jul 1;23(19):4424-9. doi: 10.1200/JCO.2005.15.651. PMID 15994152
- RESULTShigematsu H, Hirata T, Nishina M, Yasui D, Ozaki S. Cryotherapy for the prevention of weekly paclitaxel-induced peripheral adverse events in breast cancer patients. Support Care Cancer. 2020 Oct;28(10):5005-5011. doi: 10.1007/s00520-020-05345-9. Epub 2020 Feb 8. PMID 32036471
- RESULTHanai A, Ishiguro H, Sozu T, Tsuda M, Yano I, Nakagawa T, Imai S, Hamabe Y, Toi M, Arai H, Tsuboyama T. Effects of Cryotherapy on Objective and Subjective Symptoms of Paclitaxel-Induced Neuropathy: Prospective Self-Controlled Trial. J Natl Cancer Inst. 2018 Feb 1;110(2):141-148. doi: 10.1093/jnci/djx178. PMID 29924336